Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Int J Mol Sci. 2024 Aug 17;25(16):8967. doi: 10.3390/ijms25168967.
Exposing cells to intense and brief electric field pulses can modulate cell permeability, a phenomenon termed electroporation. When applied in medical treatments of diseases like cancer and cardiac arrhythmias, depending on level of cellular destruction, it is also referred to as irreversible electroporation (IRE) or Pulsed Field Ablation (PFA). For ablation device testing, several pulse parameters need to be characterized in a comprehensive manner to assess lesion boundary and efficacy. Overly aggressive voltages and application numbers increase animal burden. The potato tuber is a widely used initial model for the early testing of electroporation. The aim of this study is to characterize and refine bench testing for the ablation outcomes of PFA in this simplistic vegetal model. For in vitro assays, several pulse parameters like voltage, duration, and frequency were modulated to study effects not only on 2D ablation area but also 3D depth and volume. As PFA is a relatively new technology with minimal thermal effects, we also measured temperature changes before, during, and after ablation. Data from experiments were supplemented with in silico modeling to examine E-field distribution. We have estimated the irreversible electroporation threshold in to be at 240 V/cm. This bench testing platform can screen several pulse recipes at early stages of PFA device development in a rapid and high-throughput manner before proceeding to laborious trials for IRE medical devices.
将细胞暴露于强烈而短暂的电场脉冲中可以调节细胞通透性，这种现象称为电穿孔。当应用于癌症和心律失常等疾病的医疗治疗时，根据细胞破坏程度的不同，它也被称为不可逆电穿孔（IRE）或脉冲场消融（PFA）。对于消融设备的测试，需要全面地描述几个脉冲参数，以评估病变边界和疗效。过于激进的电压和应用次数会增加动物的负担。土豆块茎是电穿孔早期测试的广泛使用的初始模型。本研究的目的是在这个简单的植物模型中对 PFA 的消融结果进行特征描述和优化 bench 测试。对于体外分析，我们可以调节电压、持续时间和频率等几个脉冲参数，不仅研究二维消融面积的影响，还研究三维深度和体积的影响。由于 PFA 是一种相对较新的技术，热效应最小，因此我们还测量了消融前后的温度变化。实验数据辅以数值模拟，以检查电场分布。我们已经估计出在 中的不可逆电穿孔阈值为 240 V/cm。在进行耗时的 IRE 医疗器械试验之前，这个 bench 测试平台可以在 PFA 设备开发的早期阶段快速、高通量地筛选出几种脉冲方案。
